UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004094 |
|---|---|
| Receipt number | R000004889 |
| Scientific Title | Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2010/10/26 14:21:02 |
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Basic information
Public title
Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects
Acronym
Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects
Scientific Title
Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects
Scientific Title:Acronym
Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects
Region
| Japan |
Condition
Condition
Healthy male subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the role of MDR1 and CYP3A4 in intestinal absorption of Quinidine and Verapamil.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics of Quinidine and Verapamil
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Quinidine,Verapamil,Fexofenadine,Midazolam,Celiprolol and Itraconazole
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
Key criteria to be considered for this study:
(1)Healthy male subjects
(2)The subject is capable of giving written consent prior to screening.
(3)The subject aged between 20 and 45 years inclusive at screening.
(4)The subject has a body mass index in the range of 17.6 to 28.0 kg/m2.
(5)The subject is able to abstain from smoking during the hospitalization.
Key exclusion criteria
The following subjects shall be excluded from this study:
(1)The subject has any medical history that is not considered as eligible for
inclusion in this study by the investigator.
(2)The subject has the disease which needs a treatment at present.
(3)The subject is currently participating in another clinical study and is exposed to an investigational drug.
(4) The subject has any medical history of known allergy or hypersensitivity to quinidine, verapamil, fexofenadine, midazolam, celiprorol and itraconazole.
(5) The subject has donated whole blood">400mL" within the previous 3 months or ">200mL" within the previous 1 month, and components of blood(apheresis) within the previous 2 weeks.
(6) The subject has hypersensitivity to any drugs and foods.
(7) The subject has a history or current conditions of drug abuse or alcoholism.
(8)The subject is positive for HBs antigen, syphilis, HCV antibody, HIV antigen/antibody.
(9)The subject has any clinically relevant abnormality on vital sign, clinical laboratory test, ECG and medical examination. (The subject who admitted participation in this study in the judgement of investigator excludes.)
(10)Any subjects considered to be unsuitable for the study by the reseacher.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Komatsuzaki |
Organization
Tsukuba International Clinical Pharmacology Clinic
Division name
medical office
Zip code
Address
1-21-16 Kannondai Tsukuba city,Ibaraki,JAPAN
TEL
029-839-1150
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Mochii |
Organization
Tsukuba International Clinical Pharmacology Clinic
Division name
Clinical Trial Project Office
Zip code
Address
1-21-16 Kannondai Tsukuba city,Ibaraki,JAPAN
TEL
029-839-1150
Homepage URL
m-mochii@tsukuba-icp.jp
Sponsor or person
Institute
APDD
Institute
Department
Personal name
Funding Source
Organization
APDD
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 24 | Day |
Last modified on
| 2010 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004889
